The FDA released a warning letter sent to Chinese API maker Qinhuangdao Zizhu Pharmaceutical in April that outlined data integrity problems.
Seqirus said it has achieved an industry first by producing a cell-based influenza vaccine on a commercial scale using a virus grown in cells.
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Citing sterility concerns, Hospira, a subsidiary of pharma giant Pfizer, is voluntarily recalling vials used to inject sodium bicarbonate during surgery and in…
Japanese pharmaceutical giant Takeda said it has completed construction of its new $111 million manufacturing plant in Oranienburg, Germany.
The FDA has banned drugs manufactured at three facilities in India operated by Ipca Laboratories as a result of ongoing concerns.
Bristol-Myers Squibb will unload an API plant in Ireland to a South Korean company with large aspirations in contract manufacturing.
Bristol-Myers Squibb recalled a lot of its anticoagulant Eliquis after discovery of a bottle that contained tablets that were half the prescribed dose.
The European Union this week posted regulations that upon the U.K.’s exit for the EU its API makers will be treated like those from China and India.
Particle Sciences will have commercial manufacturing capabilities operating at its Pennsylvania facility by the end of the year and will add 30 jobs.
With biologics dominating its pipeline, Sanofi will spend as much as $2 billion on its biologics manufacturing network over the next several years.